EN ISO 7153-1:2016

Surgical instruments - Materials - Part 1: Metals (ISO 7153-1:2016)

ISO 7153-1:2016 specifies metals commonly used to manufacture various types of standard surgical instruments, including but not limited to those used in general surgery, orthopaedics and dentistry.
While ISO 7153-1:2016 is not intended for surgical instruments used in special applications, such as implantology and minimally invasive surgery, parts of it might be applicable to those instruments.

Chirurgische Instrumente - Werkstoffe - Teil 1: Metalle (ISO 7153-1:2016)

Instruments chirurgicaux - Matériaux - Partie 1: Métaux (ISO 7153-1:2016)

ISO 7153-1:2016 spécifie les métaux couramment utilisés pour la fabrication de différents types d'instruments chirurgicaux normalisés, incluant, sans toutefois s'y limiter, ceux employés en chirurgie générale, en chirurgie orthopédique et en médecine bucco-dentaire.
Bien que l'ISO 7153-1:2016 ne soit pas destiné aux instruments chirurgicaux utilisés dans des applications particulières, telles que l'implantologie et la chirurgie mini-invasive, des parties de ce document pourraient s'y appliquer.

Kirurški instrumenti - Materiali - 1. del: Kovine (ISO 7153-1:2016)

Ta del standarda ISO 7153 določa kovine, ki se običajno uporabljajo za izdelavo različnih vrst standardnih kirurških instrumentov, kar brez omejitev vključuje instrumente za uporabo na področju splošne kirurgije, ortopedije in zobozdravstva.
Ta del standarda ISO 7153 sicer ni namenjen za kirurške instrumente za posebno uporabo, na primer implantologijo in minimalno invazivne kirurške posege, vendar se lahko deloma uporablja za takšne instrumente.
OPOMBA: pri izbiranju razreda jekla ter oblike, dimenzije in dobavnih pogojev surovine za proizvodnjo kirurških instrumentov je treba upoštevati dejavnike, kot je zasnova instrumenta ali proizvajalčevi proizvodni obrati, kar ni zajeto v tem delu standarda ISO 7153.
Zato ni predvideno niti možno, da bi lahko bila na podlagi informacij v tem delu standarda ISO 7153 proizvajalcu instrumenta odvzeta odgovornost odločanja glede izbire ustrezne surovine s primernimi lastnostmi. Prav tako ni predvidena izključitev uporabe drugih vrst jekla (npr. ogljikovega jekla za rezalne instrumente) v proizvodnji instrumentov. To odločitev je mogoče sprejeti v skladu z objavljenimi mednarodnimi standardi za kirurške instrumente, saj lahko vsebujejo dodatne ali nove informacije, ki jih je treba upoštevati pri izbiri ustreznih razredov jekla.

General Information

• Status: Published
• Publication Date: 25-Oct-2016
• Withdrawal Date: 29-Apr-2017
• ICS: 11.040.30 - Surgical instruments and materials
• ICS: 77.140.20 - Stainless steels
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 26-Oct-2016
• Completion Date: 26-Oct-2016
• Ref Project: SIST EN ISO 7153-1:2017 - Surgical instruments - Materials - Part 1: Metals (ISO 7153-1:2016)

Relations

• Replaces: EN ISO 7153-1:2000 - Surgical instruments - Metallic materials - Part 1: Stainless steel (ISO 7153-1:1991, including Amendment 1:1999)
• Effective Date: 02-Nov-2016

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 7153-1:2017
01-januar-2017
1DGRPHãþD
SIST EN ISO 7153-1:2001
Kirurški instrumenti - Materiali - 1. del: Kovine (ISO 7153-1:2016)
Surgical instruments - Materials - Part 1: Metals (ISO 7153-1:2016)
Chirurgische Instrumente - Werkstoffe - Teil 1: Metalle (ISO 7153-1:2016)
Instruments chirurgicaux - Matériaux - Partie 1: Métaux (ISO 7153-1:2016)
Ta slovenski standard je istoveten z: EN ISO 7153-1:2016
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
77.140.20 Visokokakovostna jekla Stainless steels
SIST EN ISO 7153-1:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 7153-1:2017

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SIST EN ISO 7153-1:2017


EN ISO 7153-1
EUROPEAN STANDARD

NORME EUROPÉENNE

October 2016
EUROPÄISCHE NORM
ICS 11.040.30; 77.140.20 Supersedes EN ISO 7153-1:2000
English Version

Surgical instruments - Materials - Part 1: Metals (ISO
7153-1:2016)
Instruments chirurgicaux - Matériaux - Partie 1: Chirurgische Instrumente - Werkstoffe - Teil 1: Metalle
Métaux (ISO 7153-1:2016) (ISO 7153-1:2016)
This European Standard was approved by CEN on 10 September 2016.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7153-1:2016 E
worldwide for CEN national Members.

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SIST EN ISO 7153-1:2017
EN ISO 7153-1:2016 (E)
Contents Page
European foreword . 3

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SIST EN ISO 7153-1:2017
EN ISO 7153-1:2016 (E)
European foreword
This document (EN ISO 7153-1:2016) has been prepared by Technical Committee ISO/TC 170 “Surgical
instruments” in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which
is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2017, and conflicting national standards shall be
withdrawn at the latest by April 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 7153-1:2000.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 7153-1:2016 has been approved by CEN as EN ISO 7153-1:2016 without any
modification.
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SIST EN ISO 7153-1:2017
INTERNATIONAL ISO
STANDARD 7153-1
Third edition
2016-10-01
Surgical instruments — Materials —
Part 1:
Metals
Instruments chirurgicaux — Matériaux —
Partie 1: Métaux
Reference number
ISO 7153-1:2016(E)
©
ISO 2016

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